Recommendation of adjuvant trastuzumab treatment in HER-2-positive breast cancer patients: insights from quality indicator data collected in certified breast cancer centers in Germany, Italy, Austria, and Switzerland.

PURPOSE: In 2003, a certification system was introduced to ensure high standards of oncological care in breast cancer patients in Germany. Certified breast cancer centers (BCCs) must fulfill specific requirements including quality indicators (QI) derived from the clinical guidelines that are evaluated in annual audits. When target values for QIs are not fulfilled, centers need to give explanations. We analyzed data from BCCs for a selected indicator: the recommendation of trastuzumab for patients with early HER-2-positive invasive breast cancer. We investigated explanations given in cases when trastuzumab was not recommended to see whether this was justified. METHODS: Patient data from 274 BCCs treating 53,777 primary cases in 2015 were analyzed using descriptive statistics. RESULTS: In the 274 BCC sites, 5700 primary patients with early HER-2-positive breast cancer were treated in 2015. 128 sites (46.7%) did not reach the target value of 95% trastuzumab recommendation and thus had to give explanations. In these 128 sites, 2663 primary HER-2-positive breast cancer patients were treated, 343 (12.9%) of whom did not receive a recommendation for adjuvant trastuzumab treatment. All 128 sites delivered explanations. Overall, 450 explanations were given, allowing multiple explanations for single patients. No explanation was given for 8 of the 343 patients (2.3%). The most common given explanation was multi-/comorbidity (45.5%). CONCLUSIONS: The analysis suggests thorough decision-making when quality indicator target values for a trastuzumab recommendation were not fulfilled. Our data do not provide information on whether such decisions have an impact on treatment outcome for these patients.

[Obstacles and facilitators of conducting studies - the perspective of colorectal cancer centers' coordinators]. / Hemmende und fördernde Faktoren bei der Durchführung von Studien - Die Sicht von Darmkrebszentrumskoordinatorinnen und -koordinatoren.

INTRODUCTION: Clinical trials and health services research are crucial pillars for improving patient care. This paper examines factors inhibiting and promoting the study activity and the knowledge and use of trial registries (e. g. DRKS, StudyBox) as an opportunity to learn about existing studies. MATERIAL AND METHODS: The coordinators of 274 cancer center sites certified according to the requirements of the German Cancer Society were surveyed using a standardized online questionnaire. Data were analyzed using descriptive and bivariate statistics to identify associations with characteristics of the sites (e. g. patient volume, ownership, teaching status). RESULTS: 176 sites participated in the survey (64.2 %). The central obstacle to study participa-tion from the centers' view is the low number of existing studies. General knowledge of the population about studies was considered low. Trial registries are known to almost all respondents, but are rarely used. DISCUSSION: The results of the survey suggest that comprehensive measures are needed to sustainably increase the study activity. These include, for example, better information about studies, for example through appropriate databases, and (industry-independent) research funding. One possible way to sensitize patients for studies could be the comprehensive education of the population about the purpose of studies.

[Quality of Care in Certified Lung Cancer Centers]. / Versorgungsqualität in zertifizierten Lungenkrebszentren.

BACKGROUND: Since 2008, lung cancer centers can be certified in accordance with the criteria set out by the German Cancer Society (Deutsche Krebsgesellschaft). This paper reports on the certification program for lung cancer centers and presents data on 18 quality indicators collected during certification. METHODS: After checks for plausibility and completeness, data on quality indicators for the 2011 and 2012 patient cohorts as well as data of the treating centers were analyzed descriptively (relative/absolute frequencies, means, site medians). PATIENTS: 23,222 patients with ICD-10 diagnoses C33 und C34 from 35 (2012) and 24 operating sites (2011), respectively. RESULTS: From 2011 to 2012, both the number of certified sites and the number of patients treated increased. Fulfillment of the certification requirements is already high and improved slightly from 2011 to 2012. The implementation of indicators without target values is less advanced. CONCLUSION: Thanks to the medical and professional associations as well as the oncologic medical experts, the lung cancer certification program is evolving continuously. There has been a steady increase both in the number of patients treated and the number of lung cancer centers; certification requirements are also being increasingly fulfilled.

Documented quality of care in certified colorectal cancer centers in Germany: German Cancer Society benchmarking report for 2013.

PURPOSE: In order to improve the quality of treatment for cancer patients the German Cancer Society (Deutsche Krebsgesellschaft) implemented a certification system for oncological care institutions. The certified colorectal cancer centers present the structures, processes and results of their network in the framework of an auditing procedure. METHODS: The current benchmarking report by the certified centers reflects the centers' reference results over a period of 3 years. The figures included in the benchmarking report reflect the areas of interdisciplinary collaboration, guideline-compliant treatment, and expertise of the main treatment partners. RESULTS: High percentages were shown for indicators reflecting pretreatment and postoperative case presentations in multidisciplinary team meetings (91.8 % or 98.1 %), psycho-oncologic care (54.8 %) as well as social service counseling (77.1 %). Good quality of the TME rectal specimen and adequate lymph-node retrieval (12 lymph nodes at least) was achieved by 93 % or 96.6 % of the centers. Adjuvant chemotherapy (colon, Union for International Cancer Control [UICC] stage III) or neoadjuvant radiotherapy or chemoradiotherapy (rectum, UICC stages II and III) received 73.7 % or 80 % of relevant patients. Quotas of anastomotic leakage in the colon or rectum were 4.4 % or 7.6 %, whereas postoperative mortality amounted to 2.6 %. CONCLUSIONS: The present analysis of the results, together with the centers' statements and the auditors' reports, shows that most of the targets for indicator figures are being better met over the course of time. In addition, however, there is a clear potential for improvement and the centers are verifiably addressing this. A transparent presentation of the quality of care and reflection on and discussion of the results among the treatment partners in the certified network and with the auditors during the certification process may contribute to constant quality improvement in oncological care.

Current clinical practice and outcome of neoadjuvant chemotherapy for early breast cancer: analysis of individual data from 94,638 patients treated in 55 breast cancer centers.

Neoadjuvant chemotherapy (NACT) is frequently used in patients with early breast cancer. Randomized controlled trials have demonstrated similar survival after NACT or adjuvant chemotherapy (ACT). However, certain subtypes may benefit more when NACT contains regimes leading to high rates of pathologic complete response (pCR) rates. In this study we analyzed data using the OncoBox research from 94,638 patients treated in 55 breast cancer centers to describe the current clinical practice of and outcomes after NACT under routine conditions. These data were compared to patients treated with ACT. 40% of all patients received chemotherapy. The use of NACT increased over time from 5% in 2007 up to 17.3% in 2016. The proportion of patients receiving NACT varied by subtype. It was low in patients with HR-positive/HER2-negative breast cancer (5.8%). However, 31.8% of patients with triple-negative, 31.9% with HR-negative/HER2-positive, and 26.5% with HR-positive/HER2-positive breast cancer received NACT. The rates of pCR were higher in patients with HR-positive/HER2-positive, HR-negative/HER2-positive and triple-negative tumors (36, 53 and 38%) compared to HR-positive/HER2-negative tumors (12%). PCR was achieved more often in HER2-positive and triple-negative tumors over time.This is the largest study on use and effects of NACT in German breast cancer centers. It demonstrates the increased use of NACT based on recommendations in current clinical guidelines. An improvement of pCR was shown in particular in HER2-positive and triple-negative breast cancer, which is consistent with data from randomized controlled trails.

Association of bone marrow lesions with knee structures and risk factors for bone marrow lesions in the knees of clinically healthy, community-based adults.

OBJECTIVES: Subchondral bone marrow lesions (BML) are involved in pain and progression of knee osteoarthritis (OA). Little is known about their role in the knee in those without clinical OA. Our aim was to examine the prevalence and risk factors for BML, and their relationship with other knee structures in community-based adults without clinical OA. METHODS: Two hundred ninety-seven healthy subjects without knee pain or injury were recruited from an existing community-based cohort recruited at baseline in 1990-1994. Subjects with a single magnetic resonance imaging (MRI) of their dominant knee at follow-up were studied in 2003-2004. BML, cartilage defects, cartilage volume, and bone area of the knee were assessed using MRI. RESULTS: Thirty-nine subjects (13%) had evidence of BML. BML were associated with the presence of cartilage defects in the medial (odds ratio (OR) 1.80, P = 0.004) and lateral (OR 1.45, P = 0.04) tibiofemoral compartments, but not cartilage volume. BML were positively associated with total tibial bone area (OR 1.22, P = 0.02). Increasing age (OR 1.10, P < 0.001), male gender (OR 3.86, P = 0.01), and increasing body height (OR 1.07, P = 0.03) were independently associated with BML in the total tibiofemoral compartment. CONCLUSIONS: BML are present in the knees of community-based adults without clinical OA and are strongly associated with tibiofemoral cartilage defects. Risk factors for BML were age, male gender, and body height. Longitudinal studies will be needed to clarify the role of BML in structural change of the knee and how this relates to the pathogenesis of symptomatic knee OA.

TRANSLATION AND ADAPTATION OF COMPUTER ASSISTED SMOKING PREVENTION PROGRAM IN ROMANIA (ASPIRA).

ASPIRA smoking prevention online program consists in studying five modules that include tests, videos and interactive games. It was tested on a group of schoolchildren and students from Tîrgu Mures by completing a questionnaire with reference to the opinions of the young people and the functionality of the software. The vast majority of those questioned reported a good or very good impression about the ASPIRA program and believed that the information presented was suitable. High school pupils and boys were more critical.

Vancomycin concentration in the vitreous after intravenous and intravitreal administration for postoperative endophthalmitis.

OBJECTIVES: To measure the concentrations of vancomycin in the vitreous of patients with postoperative endophthalmitis after administration of 1 g of vancomycin hydrochloride intravenously and injection of 1 mg of vancomycin hydrochloride into the vitreous, and to determine whether these concentrations are adequate for treatment of gram-positive infections. METHODS: Patients with acute postoperative endophthalmitis were treated with intravenous administration of 1 g of vancomycin hydrochloride followed by vitrectomy and collection of vitreous samples 1 to 5 hours later. Intravitreal vancomycin and ceftazidime were given. Vitreous samples were cultured and their vancomycin concentrations assayed. Minimal inhibitory concentrations of vancomycin for the isolated vitreal pathogens, and serum and vitreous cidal activity were determined. RESULTS: Eighteen patients with acute postoperative endophthalmitis were studied. Fourteen vitreous samples were available after intravenous vancomycin administration, and 4 vitreous samples were available after intravitreal vancomycin administration. After intravenous injection, vitreous vancomycin concentrations ranged from 0.4 to 4.5 microg/mL. Minimal inhibitory concentrations in these samples, obtained from 10 bacterial isolates, were below the therapeutic levels for most causative organisms, including staphylococci. Vitreous cidal activity values were negative at a dilution of 1:2 in 9 of 10 patients examined. After a 1-mg intravitreal injection, vancomycin concentrations in vitreous samples obtained by a second tap from 4 patients 44 to 72 hours later were 182, 138, 58, and 25 microg/mL. In 2 patients in whom measurements were obtained, vitreous cidal activity values were 1:512 and 1:32. CONCLUSION: Vitreous vancomycin concentrations for the treatment of gram-positive endophthalmitis were nontherapeutic after intravenous administration but therapeutic after intravitreal administration.

Training issues in emergency psychiatry.

The psychiatric emergency service (PES) is an excellent learning environment that offers trainees a multitude of educational opportunities. PES personnel need to develop training programs to ensure that psychiatry residents obtain knowledge and skills in emergency evaluation, crisis management, and triage of patients, as required by accreditation bodies. Curriculum guidelines can best be achieved through a rotation that offers an orientation, didactic presentations, clinical supervision, and graded responsibilities. Improved training opportunities, senior electives, and fellowships will promote emergency psychiatry as a career choice.

Splinting.

The definitions of splinting, occlusal trauma, and mobility have been described. The history of splinting as a treatment for periodontal disease has been noted along with the current concepts of the indications and rationale for splinting. Splints have been classified according to their expected length of service: short-term splints, provisional splints, and long-term splints. The disadvantages of splinting have been enumerated, and examples of the various types of splints currently employed have been demonstrated.

Utilizing gravity in the removal of a large intraocular foreign body.

This article describes an unconventional technique for the removal of a nonmagnetic intraocular foreign body that is too large or too smooth to be grasped by intraocular forceps and does not float on perfluorocarbon liquids. By flipping the patient to a face-down position and allowing the gravitational forces to help remove the object, one can hope to avoid further ocular damage. This approach should be considered in similar cases of very large and smooth intravitreal foreign bodies to avoid severe and irreversible damage to the retina.

Reliability of reduced-thickness and thinly veneered lithium disilicate crowns.

The present investigation hypothesized that the reliability of reduced-thickness monolithic lithium disilicate crowns is high relative to that of veneered zirconia (Y-TZP) and comparable with that of metal ceramic (MCR) systems. CAD/CAM first mandibular molar full-crown preparations were produced with uniform thicknesses of either 1.0-mm or 2.0-mm occlusal and axial reduction, then replicated in composite for standard crown dies. Monolithic 1.0-mm (MON) and 2.0-mm CAD/CAM lithium disilicate crowns, the latter with a buccal thin veneer (BTV) of 0.5 mm, were fabricated and then sliding-contact-fatigued (step-stress method) until failure or suspension (n = 18/group). Crack evolution was followed, and fractography of post mortem specimens was performed and compared with that of clinical specimens. Use level probability Weibull calculation (use load = 1,200 N) showed interval overlaps between MON and BTV. There was no significant difference between the Weibull characteristic failure loads of MON and BTV (1,535 N [90% CI 1,354-1,740] and 1,609 N [90% CI 1,512-1,712], respectively), which were significantly higher than that of Y-TZP (370 N [90% CI 322-427]) and comparable with that of MCR (1,304 N [90% CI 1,203-1,414]), validating the study hypothesis.

Reliability of metalloceramic and zirconia-based ceramic crowns.

Despite the increasing utilization of all-ceramic crown systems, their mechanical performance relative to that of metal ceramic restorations (MCR) has yet to be determined. This investigation tested the hypothesis that MCR present higher reliability over two Y-TZP all-ceramic crown systems under mouth-motion fatigue conditions. A CAD-based tooth preparation with the average dimensions of a mandibular first molar was used as a master die to fabricate all restorations. One 0.5-mm Pd-Ag and two Y-TZP system cores were veneered with 1.5 mm porcelain. Crowns were cemented onto aged (60 days in water) composite (Z100, 3M/ESPE) reproductions of the die. Mouth-motion fatigue was performed, and use level probability Weibull curves were determined. Failure modes of all systems included chipping or fracture of the porcelain veneer initiating at the indentation site. Fatigue was an acceleration factor for all-ceramic systems, but not for the MCR system. The latter presented significantly higher reliability under mouth-motion cyclic mechanical testing.

Prognostic factors for visual acuity improvement after intravitreal triamcinolone injection.

PURPOSE: In some patients with macular oedema, intravitreal triamcinolone acetonide injection (IVTA) fails to improve visual acuity, although oedema shows clinical and angiographic improvement. Side effects can include increased intraocular pressure, cataract development, and (rarely) endophthalmitis. Our purpose was to identify prognostic factors for visual acuity improvement after IVTA. METHODS: Data on patients treated by IVTA for macular oedema were retrospectively reviewed. Three months postinjection, visual acuity was rated as 'improved' (two or more Snellen lines gained) or 'nonimproved' (unchanged or worsened). Comparative demographic data and pre- and post-IVTA clinical and fluorescein angiographic findings were analysed with SPSS software. RESULTS: Of 57 eyes (57 patients), 27 (47%) improved after IVTA. Initial visual acuity ('good', 'moderate', or 'poor') and aetiology of macular oedema (diabetic, venous occlusion, or pseudophakic) did not differ between the two groups. Improvement occurred in significantly more eyes with clinical or angiographic evidence of cystoid macular oedema (CME) than in those with diffuse retinal thickening (P=0.04) or diffuse leakage on fluorescein angiography (P=0.02), respectively, and in significantly more pseudophakic than phakic eyes (P=0.046). CONCLUSIONS: Pseudophakia and clinical or angiographic CME, but not aetiology or initial visual acuity, were prognostic of visual acuity improvement after IVTA for macular oedema.

Maintaining and enhancing gingival architecture in fixed prosthodontics.

The long-term success of fixed prosthodontic restorations is greatly dependent upon the health and stability of the surrounding periodontal structures. This article deals with the interrelationship between fixed prosthodontic procedures and the stability and health of the periodontium. The commonly encountered problem of alterations in gingival architecture is examined in relation to tooth preparation as well as soft tissue preparation. In addition, the ability of the provisional restoration to guide soft tissue form is discussed as well as the role of the final restoration in providing long-term tissue maintenance. Key factors such as margin placement, tissue damage during tooth preparation, the role of the provisional restoration, tissue injury during impression procedures, crown contour, pontic design, and embrasure design are covered in detail.

Tensile strength analysis of midpontic soldering.

A total of 120 three-unit fixed partial dentures were made by using a latex mold to produce uniform wax patterns. Four groups were used to compare the tensile strength of connectors with interproximal solder, midpontic vertical solder, midpontic diagonal solder, and a control of one-piece castings. Three different metals were tested and the tensile load required to fracture the samples as well as the fracture sites were recorded. The following was found: Soldering the interproximal connector area produced the weakest solder joints, regardless of metal tested, at p less than .001. There was no significant difference in the fracture loads between midpontic vertical soldering and midpontic diagonal soldering with all three metals at p less than .01. There was no significant difference in fracture loads between midpontic soldering and unit casting with all three metals at p less than .01. The extreme variations in fracture loads when soldering nickel-chrome-beryllium confirms the technique sensitivity of presoldering this alloy.

A predoctoral honors program in prosthodontics.

Over the last 25 years, the advent of new disciplines in dental education and the increasing body of knowledge in various dental specialties have led to a struggle for curriculum hours within many dental schools. At the same time, the amount of time available for teaching clinical skills in dental schools has not increased appreciably, and fewer patients require (or can afford) sophisticated prosthodontic treatment. As a result of these trends, there has been a general decline in the depth and range of clinical skills of recent dental school graduates, particularly in prosthodontics. New York University College of Dentistry has attempted to address this problem by establishing a predoctoral honors program in prosthodontics.

Cost savings associated with fitness-to-stand-trial assessments in detention centres: a pilot program.

OBJECTIVE: To determine whether fitness-to-stand-trial assessments "in detention" offer cost benefit over inpatient assessments. METHOD: The development of a pilot "fitness clinic" in a detention centre is described, and the results of 1 year of assessments are presented. The cost benefit of fitness assessments conducted in detention centres is outlined. RESULTS: Significant cost savings were realized by operating fitness clinics in detention centres. CONCLUSION: Fitness clinics in detention centres offer important benefits and are recommended as an adjunct to forensic programs.

[Management of the complications of severe fractures with external fixator (author's transl)]. / A súlyos csonttörés szövödményeinek kezelése külsö rögzítövel.

After a chronological review the advantages of this method are reviewed here, together with the indications. The different types of fixator are demonstrated in some of their cases. It is emphasized, that this method is complementary to the internal fixation, and the indications of its use are made in an increasing number of cases, such as in septic complications as well as 3rd degree compound fractures, delayed unions etc.

Urticaria in idiopathic bilateral recurrent branch retinal arterial occlusion.

Idiopathic bilateral recurrent branch retinal arterial occlusion (IBRBRAO) is a rare syndrome characterized by migraine headaches, tinnitus, vertigo, hearing loss, and recurrent branch retinal artery occlusion of unknown etiology. Affected patients frequently undergo a wide range of medical evaluation and have no apparent pathologic findings. We present here a case of IBRBRAO, associated with urticarial rash, not described in this syndrome in previous publications.